1. The Field of the Invention
The present invention relates generally to electrosurgical systems. More specifically, the present invention relates to electrosurgical return electrodes that are adapted for providing safe and effective electrosurgery.
2. The Relevant Technology
As is known to those skilled in the art, modern surgical techniques typically employ radio frequency (RF) power to cut tissue and coagulate bleeding encountered in performing surgical procedures. For historical perspective and details of such techniques, reference is made to U.S. Pat. No. 4,936,842, issued to D'Amelio et al., and entitled “Electroprobe Apparatus,” the disclosure of which is incorporated by this reference.
As is known to those skilled in the medical arts, electrosurgery is widely used and offers many advantages including the use of a single surgical tool for both cutting and coagulating the tissue of a patient. Every monopolar electrosurgical generator system must have an active electrode that is applied by the surgeon to the patient at the surgical site and a return path from the patient back to an electrosurgical generator that provides the RF power used during electrosurgical procedures. The active electrode at the point of contact with the patient must be small to produce a high current density resulting in a surgical effect of cutting or coagulating tissue. The return electrode, which carries the same current as the active electrode, must be large enough in effective surface area at the point of communication with the patient so that the density of the electrosurgical current flowing from the patient to the return electrode is limited to safe levels. If the density of the electrosurgical current is relatively high at the return electrode, the temperature of the patient's skin and tissue will rise in this area and can result in an undesirable patient burn.
In 1985, the Emergency Care Research Institute, a well-known medical testing agency, published the results of testing it had conducted on electrosurgical return electrode site burns, stating that the heating of body tissue to the threshold of necrosis occurs when the current density exceeds 100 milliamperes per square centimeter. The Association for the Advancement of Medical Instrumentation (“AAMI”) has published standards that require that the maximum patient surface tissue temperature adjacent an electrosurgical return electrode should not rise more than six degrees (6°) Celsius under stated test conditions.
Over the past twenty years, products have been developed in response to the medical need for a safer return electrode. One advancement in return electrode technology was the development of a flexible electrode to replace the small, about 12×7 inches, flat stainless steel plate electrode typically in use during electrosurgical procedures. This plate electrode was typically coated with a conductive gel, placed under the patient's buttocks, thigh, shoulders, or any other location, and relied upon gravity to ensure adequate contact area. These flexible electrodes, which are generally about the same size as the stainless steel plates, are coated with a conductive or dielectric polymer and have an adhesive border on them so they will remain attached to the patient without the aid of gravity. By the early 1980's, most hospitals in the United States were using flexible electrodes. Flexible electrodes resulted in fewer patient return electrode burns but resulted in additional surgical costs in the United States of several tens of millions of dollars each year because each electrode had to be disposed of after use. Even with this improvement, hospitals were still experiencing some patient burns caused by electrodes that would accidentally fall off or partially separate from the patient during surgery.
In an attempt to minimize the potential for patient burns, contact quality monitoring systems were developed. Contact quality monitoring systems are adapted to monitor the contact area of an electrode that is in contact with a patient and turn off the electrosurgical generator whenever there is insufficient contact area between the patient and the electrode. Such circuits are shown, for example, in U.S. Pat. No. 4,200,104 issued to Harris, and entitled “Contact Area Measurement Apparatus for Use in Electrosurgery” and; U.S. Pat. No. 4,231,372, issued to Newton, and entitled “Safety Monitoring Circuit for Electrosurgical Unit,” the disclosures of which are incorporated by this reference. Contact quality monitoring systems have resulted in additional reduction in patient return electrode burns, but require special disposable electrodes, resulting in an increase in the cost per procedure. Twenty years after these systems were first introduced, only 75 percent of all the surgical operations performed in the United States use contact quality monitoring systems because of the increased costs and other factors.
Self-limiting electrosurgical return electrodes provide an alternative to contact quality monitoring systems. Self-limiting electrosurgical return electrodes allow electrosurgery to be performed when the contact area between the patient and the pad is sufficient to limit the density of the electrosurgical current to safe levels and when there are not too many materials placed between the patient and the pad. When the contact area between the patient and the return electrode falls below a minimum contact area or when too many materials are placed between the patient and the pad, the properties of the pad limit the flow of current to prevent a patient burn.
While self-limiting electrodes are typically reusable and provide current limiting, the impedance properties of the pad can result in unnecessary limiting of the electrosurgical current even where the contact area is sufficient to prevent patient burns. For example, during surgeries that require high current flow such as trans-urethral resection of the prostate procedures (TURP), though the contact area may be sufficient to conduct safe electrosurgery, small increases in impedance can noticeably affect the current flow. Additionally, procedures involving small pediatric patients can result in diminished current flow due to the relatively small contact area of the patient with the pad and the resulting increases in impedance. This is particularly true for neonatal patients, where the small size and mass of the patients have rendered present applications impractical.